One example of product risk would be failing of a software used in a product. As an engineer, I would verify and validate the software used in the product during the executing process. Once the software is validated, any component of it used in the product would not raise a doubt or risk later on in the project. Also, as a part of the team I would make sure to raise this concern during the meetings and make sure that the project manager as all as other team members are aware of the potential risk in the software used in this project. This again emphasis on the importance of review meetings where everyone should discuss any issues within the project and take the input of each team member seriously. This will make sure that the project is completed within the timeline and no extra cost is added.

Mechanical failure could be one of a product risk. Several things I would like to do to evaluate and manage risk for example I would assess the potential effects of the risk on my project then develop a plan to mitigate or eliminate the effects of that risk, monitor the status of my project’s risk throughout the process, and inform team members who are involved within the project of all risks. Discuss those risks during review meetings and get suggestions and inputs from team members.

An example that I dealt with on a team at work was on a hemostatic agent that we were releasing. The testing that we conducted with the contract lab suggested that there would be potential risk associated with the endotoxin levels in the hemostatic mesh that was in the process of being launched. The teams initial thought was to accept the risk as it would not be a large issue since the FDA stance was currently on guidelines and not hard set rules against endotoxin levels. However, the way the guidelines are being shaped it does seem inevitable that eventually these guidelines will be more than just suggestions and needed to be implemented into medical device products. We instead chose to mitigate the risk by the addition of a process step that would reduce the endotoxin levels within the hemostat. This process took longer and did increase costs of the project however it may have saved more in the long run as we don't have to worry about retroactively changing the product for that specific problem. On a side not I think the 4 risk management strategies are actually (mitigate,transfer, accept (not eliminate), and avoid).

Right now I am working for a company that designs servers used in data centers. While working on the mechanical layout of the hard drives, I noticed that their is some risk of the cable connectors being disconnected from the hard drives, especially in cases during shock & vibration and/or packaging/transporting. In order to deal with this risk, I guess you can say that the risk was mitigated because I had to design a plastic bracket that reinforced the cables connection to the hard drives. It was a very simple solution, so there was no purpose to managing that specific risk with any other solution.

As a nuclear engineer who worked on submarines, a part of the job is lowering radiation exposure or risk for the navy (the customer who works on the product). This means understanding the nature of the problem or radiation. You can mitigate the risk of exposure with time, distance and shielding. This means helping the navy develop a plan to do jobs in high radiation areas so they can minimize time, maximize distance, and have shielding in place to lower the radiation levels. This means planning jobs and mapping out the area so they are aware of the areas to avoid, and position their body during work to ensure the exposure is minimized. This also means planning an efficient job so the time is cut down. The navy also needs help as far as knowing the correct material and amount of shielding to put in place.

An example of a risk I am evaluating right now with my team, is power risk, The device we are working on depends on infrared reflection, and according to the Occupational Safety and Health Administration (OSHA) standards, there is a risk of burning the user's eye if the emitting power of the infrared is above a certain limit. We are trying to eliminate the risk by having failure plans if one of the IR led fails and the circuit design calculations to supply power to the leds is down to every possibility to help us ensure the complete elimination of that risk.

One of the projects that I worked on was to look at prints and analyze the prints for any errors or risks. I was given a CAD file of the design and had to run FEA on the design and look at areas of high stress or potential failures. As an intern, I wasn't given a critical component but just to get the experience I was given a case that contained the parts. Essentially once I ran the FEA, I looked at areas of high stress and compared it to existing dFMEA documents to give the area a rating of criticality.

In my personal experience as an electrical engineer, I have used the technique of mitigating the risk multiple times when connecting electric transformers in multiple communities. The company I worked for, had specific workers whose job was to make sure the conducting wires in utility poles have enough tension and overall in charge of connecting the circuitry in the top of the utility pole. Although when the transformer is being connected there is no current going through, there is always a risk that something could go wrong and injure the person. A way used to mitigate the risk was by implementing equipment such as stairs with glass fibers and specialized security belts. There was no way to completely reduce the risk, but it was our responsibility to lower it as much as possible.
Let me know what you think.

Sincerely,
Roberto Pineda.

A product risk can be a faulty release mechanism on a drug delivering device. Under FMEA this would be a Concept Design / Hardware risk where we could monitor its probability of failure throughout its development process. Specifically, risk can be monitored with modeling software; designs would be imputed into the software then the software can assess the probability of failure for that design (like Hiren's post). If failure does occur, we can mitigate it by coming-up with different design concepts then analyze them again by functionality, risk and trade-offs with choosing one over the other. But as Roberto has said nothing is without some risk. Even the methods for evaluating risk like FMEA are not without limitations (especially since its about 60 years old now). The best we can do is lower it as much as possible.

That is a great example jvv6. I have also come across many situations in which a risk was avoidable and minor changes to design or process were able to resolve the issue. However, there are also many situations in which this is not a feasible option. In which the level of risk needs to be lowered to an acceptable level.

An example of risk that I have personally worked with was the creating of SOP's for in process checking, the SOP that was created ensured proper inspection of the manufactured product. We had to ensure that all operators were trained properly on the SOP so that our product would be manufactured to company standards. As part of the team, I have to ensure that operators will perform the SOP to its fullest capacity.

A risk is an uncertain event which can have a positive or a negative effect on a project's final product. As a project manager or a team member of that project, one of the important things I will do is to manage the risk on a daily basis. I will first try to identify the risk, then I will analyze what the likely consequences of each risk and then develop an understanding of the nature of the risks and its potential to affect project goals and objective. I will then evaluate or rank the risk by determining the risk magnitude which is the combination of likelihood and consequences. Then I will treat the risk by assessing the highest ranked risk and then set out a plan to treat or modify these risks.And at the end, I will just try to review monitor and track the risks

Medical device development is an activity that uses a variety of technological advancements and requires high levels of knowledge. Because of these and other factors, every medical device development project contains elements of uncertainty which is project risk. The success of a medical device project depends quite heavily on the amount of risk that corresponds to each project activity. As a project manager, it’s not enough to merely be aware of the risks. To accomplish a successful result, project administration must distinguish, evaluate, organize, and deal with the greater part of the significant risks.

A product risk can occur due to a defect in the drug release mechanism in a drug delivering device. Under FMEA a drug delivering device would be a Concept Design / Hardware risk where the probability of success of design needs to be monitored throughout the developmental process. Hardware risk can be monitored using a modeling software where the designs would be evaluated by the software and would be able to point out the probability of success of the hardware. In case of failure of design, we can propose a different design concept and analyze it for market requirement, functionality and risk factor.